(232 days)
The indications for use for the Passport 5L-CE Monitor include the monitoring of the following human physiological vital signs:
- Blood Oxygenation (SpO2) measurement/waveform
- ECG waveform derived from 3 or 5 Lead measurements
- Respiration rate/waveform derived from ECG or CO2
- Temperature measurement via YSI 400/700 series probes
- Invasive Blood Pressure (IBP) measurement/waveform measurable at two sites
- Non Invasive Blood Pressure (NIBP) measurement
- CO2, Inspired and end tidal mainstream/waveform
- Heart Rate derived from selected source ((SpO2, ECG, IBP, NIBP)
Passport 5L-CE Vital Signs Monitor
I apologize, but the provided text from the FDA 510(k) letter for the "Passport 5L-CE Vital Signs Monitor" does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance.
The letter primarily focuses on:
- Substantial Equivalence Determination: The FDA's finding that the device is substantially equivalent to a legally marketed predicate device.
- Regulatory Classification: Class II.
- Permitting Marketing: Allowing the device to be marketed.
- General Controls: Highlighting requirements for registration, listing, good manufacturing practice, labeling, etc.
- Indications for Use: Listing the physiological vital signs the monitor is intended to measure (SpO2, ECG, Respiration rate, Temperature, Invasive Blood Pressure, Non-Invasive Blood Pressure, CO2, Heart Rate).
It does not include:
- A table of acceptance criteria or reported device performance metrics. This type of detail would typically be found in the 510(k) submission itself, which is not provided here.
- Details of any specific study (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) conducted to demonstrate performance. The letter simply states the device is substantially equivalent, implying that its performance is comparable to the predicate device, but doesn't elaborate on the studies that supported this.
Therefore, I cannot provide a comprehensive answer to your request based solely on the provided text. To answer your questions, additional information from the actual 510(k) submission (K974178) would be required.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 26 1998
Mr. Russell Olsen Director, Product Assurance and Quality Engineering Datascope Corporation Patient Monitoring Division 580 Winters Avenue Paramus, NJ 07652
K974178 Re: Passport 5L-CE Vital Signs Monitor Regulatory Class: II (two) Product Code: DRT Dated: April 3, 1998 Received: April 6, 1998
Dear Mr. Olsen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act
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for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page I of I
510(k) Number (if known): K974178
Device Name: Passport 5L-CE
Indications For Use:
The indications for use for the Passport 5L-CE Monitor include the monitoring of the following human physiological vital signs:
- 0 Blood Oxygenation (SpO2) measurement/waveform
- ECG waveform derived from 3 or 5 Lead measurements 0
- O Respiration rate/waveform derived from ECG or CO2
- Temperature measurement via YSI 400/700 series probes ೦
- o Invasive Blood Pressure (IBP) measurement/waveform measurable at two sites
- 0 Non Invasive Blood Pressure (NIBP) measurement
- o CO2, Inspired and end tidal mainstream/waveform
- Heart Rate derived from selected source ((SpO2, ECG, IBP, NIBP) o
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use XX (Per 21 CFR 801.109) OR
Over-The-Counter Use__
(Optional Format 1-2-96)
V. Miller
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K974178
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).